Key commercial and regulatory milestones expected during the second half of 2022
New York, NY - (NewMediaWire) - June 28, 2022 - PCG Digital -- In a recent interview, Shameze Rampertab, CFO of Asensus Surgical (NYSE American: ASXC), shared more of the Performance-Guided Surgery™ company's 2022 plans and progress.
Asensus developed and commercialized a robotic surgical system-the Senhance® Surgical System-to elevate the work of surgeons and provide advanced pre-operative, intra-operative and post-operative intelligence to the surgical team. Rampertab noted that Senhance® enhances the benefits of digital laparoscopy to support better surgical outcomes as a "true differentiator" in the industry: "It's taking robotic precision, adding in digital laparoscopy, but also overlaying onto that machine vision technology, augmented intelligence, deep learning-and that is what is driving Performance-Guided Surgery. It improves the capability of surgeons and improves outcomes."
He noted that 1 in 5 surgeries today involves a complication, creating inefficiencies and systemic burdens that impact patients, providers, hospitals and reimbursement agencies.
According to Rampertab, there is a clear "need to do better. We need to increase safety, we need to reduce surgical variability, we need to guide surgeons to help them address unexpected events that happen during surgery," which is what Asensus offers with real-time clinical intelligence that enables providers to deliver value-based healthcare. He offered the analogy of the grocery store journey: If you had a complication 1 in every 5 times you drove to the store, such as the car breaking down or an accident, you would find that unacceptable. "That's what we're trying to do in the surgical realm, reduce the complication rate because it's better for everyone," he said.
By offering a digital interface between surgeon and patient, the Senhance® Surgical System is a win-win. "It's good economically and it's also good for the patients," Rampertab added. "We're going to another new level with Performance-Guided Surgery."
Asensus continued to innovate during the pandemic, launching Senhance® Connect, which allows up to six participants to connect with and support the surgeon during a procedure. When clinical teams couldn't travel or visit hospitals due to Covid-related restrictions, they were still able to offer a full virtual interface that sees what the doctor sees and offers the ability to interact.
Future advancements could include expansion of machine vision abilities. For instance, in the case of a hernia, the Senhance® system may help identify and scope out the issue, including its dimensions. Then, it could reduce the trial-and-error of sizing the mesh needed for the surgery, reducing waste and increasing efficiencies, including time and cost savings.
The company's training centers-three in the United States, two in Europe and one in Japan-are key for increasing adoption. Mobile systems make it easy to move to other locations for additional training opportunities, bringing a balance of convention and clinical utility.
Senhance® has 510(k) clearance in the United States for general laparoscopic surgical procedures and laparoscopic gynecological surgery in adults; CE mark in Europe which covers general surgery, gynecology, thoracic, and urology for adult and pediatric use; PMDA approval in Japan for general surgery, gynecology, and urology in adults and pediatrics, and a few other jurisdictions such as Taiwan. Asensus aims to file for pediatric indication under a 510(k) in the United States to further broaden potential use cases.
Further, the company reported 29% year-over-year growth with about 6,600 procedures performed using the Senhance® robot. Noting that "it's about the data," Rampertab concluded that Asensus is executing on "real strong fundamental milestones for our investors to get excited about, so more to come!"
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